• by Ted Smith , November 19, 2010

About a year ago, many of us were invited to submit oral and written comments to the Food and Drug Administration as it kicked off a new cycle of rule making -- or at least guidance -- in the broad area of online communications with specific emphasis in social media.

I recently caught up with Ramsey Baghdadi, editor of health policy magazine The RPM Report and founding member of Prevision Policy. He is arguably one of the most knowledgeable analysts on this issue and quite well-connected to FDA sources. I share here the general areas he said we should expect to see addressed.

DTC User Fees

After great efforts to get these pushed through in the last Prescription Drug User Fee Act cycle, there appears reduced interest in trying again during the current reauthorization.

Additional Guidance

Apparently, the FDA will be issuing a series of guidance documents on Internet advertising and social media. The agency says it will issue multiple guidances, not just one. Ramsey anticipates issues to be addressed in these specific areas:

• Corporate responses to unsolicited requests for information

• Corporate responsibility for correcting and monitoring third-party sites for misinformation

• Corporate accountability for having people post promotional videos

Physician Responsibilities

There will likely be more oversight in the area of physicians' off-label promotion of products.

Adverse event reporting, which occupied a lot of the air time at the 2009 public hearing, is missing from Ramsey's list. Also missing is specific guidance on levels of risk disclosure and the significant issues surrounding "one click away" notions of risk communication in short-form ads such as those in search and Twitter.

So, it may be reasonable to expect this 2010 guidance to fall more squarely into corporate communications-style issues, meaning we'll have to wait a little longer to get guidance on more product-specific advertising and the still-fuzzy zone of social media.

My read on the likely early guidance is that pharma and the agency community that supports it are being gently reminded that Direct to Consumer was never an invitation to have a Direct Relationship with a Consumer. Instead, this channel should be a carefully prescribed mechanism to help consumers seek professional care and not much more. How else might rule-makers arrive at such a collection of guidance points in the advertising area?

The only thing that responding to unsolicited consumer requests has in common with monitoring user-generated content comments and using video in corporate communications is the idea that pharma should not speak directly to consumers in any fashion other than that governed by advertising regulations. No new channels, no exceptions to the need to present fair balance at the mention of a branded treatment, and no communication to an individual that bypasses the physician.

Succeeding in a Restricted Role

It is a safe bet in my book that in this second decade of DTC advertising, while the technologies of communication and marketing have undergone massive and rapid transformation -- the fundamental restriction on the pharma industry stands unchanged. The doctor has the prescribing authority and by mandate will come between your brand and the consumer. Yes, the technology makes it possible to have robust, two-way relationships between consumers and brand, but that does not mean it is permitted.

I closed a recent conference panel with this question: Do you know how to "friend" a mime on Facebook? Someone you can talk to directly but who cannot reply to you personally? There are not many mimes on Facebook.

If that is what the DTC rules of the road are -- consumers can talk to us but we can't reply directly -- then we need to take this approach: Turn down the clamoring about why we don't think we can embrace all that the technology has to offer and instead start considering how we can let consumers know that we are speechless mimes who still want to be part of the conversation. This does not mean we cannot participate -- we just have to explain that as mimes, we have a box that is hard to escape. Have you seen great approaches to managing consumer expectation in these social environments? If so, please share in the comments below.